MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants LLC today announced the first implantation in the United States of the NUsurface® Meniscus Implant, designed to treat patients with persistent knee pain due to an injured or deteriorated meniscus. The procedure was performed by Christopher Kaeding, M.D., Professor and Executive Director, of OSU Sports Medicine at The Ohio State University Wexner Medical Center in Columbus, OH.
“There aren’t many options for these patients, unfortunately. Once the meniscus is damaged, pain sets in and can lead to arthritis and the need for knee replacement surgery,” said Dr. Kaeding. “If this implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. We’re hoping this implant can not only alleviate the pain in these patients, but help them delay or altogether avoid a knee replacement surgery.”
The procedure was performed as part of a pivotal trial to demonstrate the superiority of the NUsurface® Meniscus Implant compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery. Seven clinical sites in the United States are currently enrolling patients in the study, which is called the VENUS-trial (Verification of the Effectiveness of the NUsurface® System). Information on the study can be found at https://clinicaltrials.gov/show/NCT02108496.
“I look forward to the opportunity to offer this exciting new technology to my patients when it is available in the U.S.,” stated Elliott Hershman, M.D., Chief Medical Advisor to Active Implants. “The Venus trial is the culmination of years of development and testing of the NUsurface and follows a prospective, multi-center trial that enrolled 128 patients in centers in Europe and Israel.” Dr. Hershman is Chairman of the Department of Orthopaedics at Lenox Hills Hospital in New York and team doctor of the New York Jets.
“Clinical studies outside the U.S. have demonstrated the potential clinical benefits of our NUsurface® Meniscus Implant for patients with early knee osteoarthritis,” said Henry Klyce, Chairman and CEO of Active Implants. “We are confident that with this study we will demonstrate for superiority of the NUsurface® Meniscus Implant over standard-of-care treatments.”
About the NUsurface® Meniscus Implant: The NUsurface® Meniscus Implant is an artificial device designed to relieve knee pain and restore function similar to that of the natural healthy meniscus. The device is implanted by orthopaedic surgeons using an arthroscopic approach and a mini-open procedure. The product is approved in Europe under CE regulations and in Israel. The Company believes the NUsurface® device could treat hundreds of thousands of patients per year whose previous partial meniscectomy surgery was not successful and yet are not ready or old enough for knee arthroplasty. Active Implants estimates the potential annual worldwide market for the NUsurface® product is over $2 Billion.
The mission of Active Implants LLC is to develop orthopaedic implant solutions that integrate with the natural biomechanics of the musculoskeletal system and allow patients to maintain or return to an active lifestyle. The Company’s main focus is to develop and clinically evaluate the NUsurface® Meniscus Implant for patients with knee pain. Active Implants LLC is a privately held, multi-national company headquartered in Memphis, Tennessee USA with additional offices in Driebergen, The Netherlands, and Netanya, Israel.
For Further Information Contact:
Michael Keenan, Chief Financial Officer at 901 762-0352 or Lex R. Giltaij, M.D., M.B.A., President and Chief Operating Officer of Active Implants at +31 (343) 200 140, or email: firstname.lastname@example.org or visit: www.activeimplants.com.
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding Active Implants’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ from Active Implants’ expectations. Factors that may affect the actual results achieved by Active Implants include, without limitation, the ability of Active Implants to develop its existing and new products, technological advances and patents attained by competitors, future actions by the FDA or other regulatory agencies, domestic and foreign health care reforms and government regulations, results of pending or future clinical trials, overall economic conditions, the results of on-going litigation, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of Active Implants to integrate purchased businesses, R&D capabilities, infrastructure and employees. Active Implants does not assume any obligation to publicly update or revise any forward-looking statements for any reason.